The U.S. Food and Drug Administration (FDA) has approved two spinal cord stimulation devices from Medtronic for treatment of pain from diabetic peripheral neuropathy, according to a press release from the company.
In recent years, there has been a steady increase in therapy options for diabetic peripheral neuropathy — a common diabetes complication marked by numbness, tingling, or burning sensations, most often in the legs and feet. The available treatments don’t undo the nerve damage leading to these sensations, which can range from bothersome to extremely painful. But treatments can reduce pain and improve quality of life. The American Academy of Neurology (AAN) recently updated its guidelines on treating diabetic peripheral neuropathy, which endorse treatments ranging from oral drugs to a patch worn on the skin to implantable spinal cord stimulation devices, depending on a person’s needs.
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Medical treatments aren’t the only interventions that may reduce pain and discomfort from diabetic peripheral neuropathy. Studies have shown that neuropathy symptoms may improve if you lose excess body weight, and if you treat any vitamin D insufficiency by taking a vitamin D supplement. And you can reduce your risk for developing a diabetic foot ulcer — which is much more common in people with peripheral neuropathy — if you limit your sedentary time and get regular physical activity.
FDA approves Intellis and Vanta neurostimulators
The latest FDA approval applies to two spinal cord stimulation devices from Medtronic that are already on the market — its rechargeable neurostimulator, Intellis, and its recharge-free neurostimulator, Vanta. Both devices are already approved for the treatment of certain types of trunk or limb pain, including chronic pain in the aftermath of various types of surgery and pain associated with degenerative disk disease or a herniated disk. As a rechargeable device, Intellis is designed to allow high-dose spinal cord stimulation, and can be recharged in about an hour using a “recharge antenna” that is placed on the outside of the body close to where the internal neurostimulator is implanted. Vanta, on the other hand, is designed for lower-dose spinal cord stimulation and never needs recharging, with a battery life of up to 11 years.
Last year, the FDA approved an implantable spinal cord stimulation device — called HFX — for painful diabetic peripheral neuropathy after a clinical trial showed that the overwhelming majority of people who used the device experienced at least a 50% reduction in their pain score after one year. The latest approval of Medtronic’s devices for peripheral neuropathy is based, in part, on that study, since all spinal cord stimulation devices share basic similarities in how they work. Medtronic notes in its press release that the advantages of its devices include “multiple programming options to personalize patient therapy, unrestricted MRI access, unrivaled battery chemistry and performance, and the Medtronic TYRX Neuro Absorbable Antibacterial Envelope,” which helps reduce the risk for infection when a device is implanted.